New Chapter in the European Pharmacopoeia on Multivariate Statistical Process Control

In past September you could already read about the draft of a new Ph. Eur. chapter (5.28) regarding Multivariate Statistical Process Control (please see New Ph. Eur. chapter on statistical process control (SPC) planned). The comment period ended in September 2019. Now, this chapter has been adopted and will be published in the October 2020 issue. It is the first time that this topic is included in a pharmacopoeia. The chapter provides an introduction to the topic, but will not become legally binding. The chapter includes:

  • General Introduction
  • Introduction to Statistical Process Control (SPC)
  • Introduction to Multivariate Statistical Process Control (MSCP)
  • Theoretical background

On the website of the European Directorate for the Quality of Medicines and HealthCare (EDQM) you can find more information on this chapter under "European Pharmacopoeia: Adoption of a new general chapter on Multivariate Statistical Process Control".

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.